Panels › Orthopedic › Product code HSB · Class 2
Rod, Fixation, Intramedullary And Accessories
Regulation 888.3020
20510(k)s in 12 months (532 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
Top companies in HSB
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet, Inc. | 0 | 295 |
| DePuy Orthopaedics, Inc. | 9 | 116 |
| Zimmer GmbH | 23 | 50 |
| Stryker | 12 | 37 |
| Howmedica Osteonics | 39 | 0 |
| OrthoPediatrics Corp. | 7 | 31 |
| Ebi, L.P. | 1 | 31 |
| Advanced Orthopaedic Solutions, Inc. | 15 | 12 |
| NuVasive Specialized Orthopedics | 18 | 9 |
| Synthes (Usa) | 23 | 4 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2013 | Orthofix, Inc Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor.
The ISKD is intended for limb lengthening of the tibia and femur. Terminated |
HSB | K010322 K031219 |
| Nov 6, 2012 | Zimmer, Inc. Sirus intramedullary nail for tibia, cannulated Terminated |
HSB | K043270 |
| Nov 5, 2012 | OrthoPediatrics Corp Trochar Scalpel Instrument (Surgical Punch)
OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended Terminated |
HSB | K024173 |
| Jul 23, 2012 | Synthes USA HQ, Inc. 4.5mm TI Multiloc Screw Length 28MM-Sterile
Expiration: 04/29/2012
REF 04.019.028S
Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132
4.5MM TI Multiloc Screw Length Terminated |
HSB | K103002 |
| Jul 23, 2012 | Synthes USA HQ, Inc. 4.5mm TI Multiloc Screw Length 38MM-Sterile
Expiration: 04/29/2012
REF 04.019.038S
Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132
4.5MM TI Multiloc Screw Length Terminated |
HSB | K103002 |
| Jul 16, 2012 | Stryker Howmedica Osteonics Corp. Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Driv Terminated |
HSB | K020384 |
| May 2, 2012 | Wright Medical Technology Inc VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002.
The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotal Terminated |
HSB | K090857 |
| May 2, 2012 | Wright Medical Technology Inc VALOR(R), TARGETING GUIDE, REF 4150011000, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002.
The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal Terminated |
HSB | K090857 |
| Apr 30, 2012 | Biomet, Inc. REF 28234 Troch Nail, Long 11MM, Right 34 CM
Peritrochanteric Nail System, Rx Sterile
Biomet Trauma Persippany, NJ
Rod, Fixation, Intramedullary and Accessories
Product Usage:
An intramedullary fixa Terminated |
HSB | K050118 |
| Apr 16, 2012 | Integra LifeSciences Corp. Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tray. The product is available in six (6) sizes. All nails are color-coded for eas Terminated |
HSB | K050882 |
| Apr 2, 2012 | Acumed LLC The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is label Terminated |
HSB | K951740 |
| Nov 8, 2011 | Stryker Spine Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA
S Terminated |
HSB | None listed |
| Mar 2, 2011 | Pega Medical Inc. Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation. Terminated |
HSB | K020885 K041393 |
| Dec 28, 2010 | Zimmer Inc. Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long, Catalog 00-2490-003-50, Zimmer, Warsaw, IN.
A reusable surgical instrument used for the insertion of a Lag Screw used in the Zimme Terminated |
HSB | K091566 |
| Nov 9, 2010 | Stryker Howmedica Osteonics Corp. Nail Holding Screw; 1 unit per package
Stryker Trauma GmbH;
Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430
The nail holding Screw is used to assemble the nail to the t Terminated |
HSB | None listed |
| Nov 9, 2010 | Stryker Howmedica Osteonics Corp. External Compression Device; 1 unit per package
Stryker Trauma GmbH;
Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430
Active Apposition/compression is achieved by thread Terminated |
HSB | None listed |
| Nov 2, 2010 | Integra LifeSciences Corporation Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package.
The PANTA(R) Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot Terminated |
HSB | K050882 |
| Sep 2, 2010 | Stryker Howmedica Osteonics Corp. Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees;
Sterile, TI Alloy, Implant; Catalog number 3225-0360S.
Stryker Trauma GmbH, 24232 Schenjrchen, Germany;
distributed in USA by Howmedica Osteonic Terminated |
HSB | K034002 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-087.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-086.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-085.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-084.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-083.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-082.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-081.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-076.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-075.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-074.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-073.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-072.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-071.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-037.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-036.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-035.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-034.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-033.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-032.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-031.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-026.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-025.
The system is used for pediatric and small stature adult patients to stabilize fractures o Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-024.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-023.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-022.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 12, 2010 | Orthopediatrics Corp Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-021.
The system is used for pediatric and small stature adult patients to stabilize fractur Terminated |
HSB | K083726 |
| May 10, 2010 | Acumed LLC Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR Terminated |
HSB | K031438 |
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 12mm x 20cm x 135, Product Part Number: 1043-200. Terminated |
HSB | K021008 |
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 10mm x 20cm x 135, Product Part Number: 1042-200. Terminated |
HSB | K021008 |
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200. Terminated |
HSB | K021008 |
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 12mm x 17cm x 130, Product Part Number: 1041-170. Terminated |
HSB | K021008 |
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 10mm x 20cm x 130, Product Part Number: 1040-200. Terminated |
HSB | K021008 |
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